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Heart clot detection gets a High-Tech upgrade: new PET scan tested in rare heart disease

NCT ID NCT07560306

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests a new PET scan that uses a special tracer to find blood clots inside the heart. It involves 20 people with cardiac amyloidosis and atrial fibrillation. The goal is to see if this scan can spot clots better than current methods, which could help prevent strokes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
[64Cu]FBP8 (a radioactive tracer that binds to fibrin, a protein in blood clots)
What this could lead to
If successful, this could provide a non-invasive way to detect dangerous heart clots early, potentially reducing stroke risk in people with cardiac amyloidosis.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply to everyone. The new imaging method may not be more accurate than current standard tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have the ability to give written informed consent; * History of amyloid cardiomyopathy (ATTR-CM or AL-CM); * History of AF or AFL; * Retrospective enrollment: TEE to evaluate LAA within the previous 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE. If a patient has a negative TEE and continues the same stable anticoagulation regimen, then it is unlikely that a new thrombus will develop in the LAA within the next 14 days. Likewise, if a patient not taking any anticoagulation has a thrombus in the LAA, then it is unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient remains off anticoagulation. If the TEE leads to a change being made in the anticoagulation regimen (started/stopped/dose modified), then a time window of 72 hours from the TEE to PET/MR imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard; * Prospective: TEE to evaluate LAA thrombus scheduled in upcoming 14 days; Exclusion Criteria: * Electrical implants such as cardiac pacemaker/defibrillator, perfusion pump, direct brain stimulator; * Pregnancy or breastfeeding (a negative quantitative serum or urine hCG pregnancy test is required for females having child-bearing potential before the subject can participate); * Claustrophobia; * Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months); * Unable to lie comfortably on a bed inside the PET/MR scanner; * Subjects under direct or indirect (i.e., same department as PIs) supervision of the principal investigator; * Body weight over the weight limit for the moving table (\> 300 lbs for the MR table); * Metallic or electric implants contraindicated for PET/MR scanning; * Stroke, myocardial infarction, cardiac or major surgery within the last 3 months; * History of LAA ligation/exclusion or presence of a LAA occlusion device; * History of syncope within the last 6 weeks; * Heart rate persistently \>120 bpm or persistently \<50 bpm; * Daytime pauses \>3 seconds; * Lack of a prior transthoracic echocardiogram within the previous 6 months; * Does not have the ability to give written informed consent; * Determined by the investigator(s) to be clinically unsuitable for the study (e.g., based on screening visit and/or during study procedures);

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis disease thrombotic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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